I would like to finish up with my review of outrageous mis-information being spread about by some advocates of amniotic fluid-derived products. My focus has been on a Powerpoint presentation (PPt) made available to the public by Dr. Davidson. So far, I have pointed out what I contend are discrepancies in some of his statements, including a fantastic claim that the product Davidson uses has 44% stem cells! I will continue in this post with my points of disagreement.
The product being advocated by Dr. Davidson is injectable through presumably a 22xg or so needle, which means that the tissue is chopped up into really tiny pieces. Davidson touts a new “procedure” called cryofracture that produces injectably small pieces of tissue present in his favorite amniotic tissue-derived product. He distinguishes the product made with the cryofracture technique from products that the FDA cited for non-homologous use that were made by a technique called morcelization. He engages in this slight-of-hand in Slides 20 and 21 of his PPt. Honestly, I can’t imagine that the FDA gives a fig about how a company produces an injectable material, or what the company or its acolytes call it, since the FDA objects to the physical form of injectable amniotic membrane-derived material and its inability to serve as a barrier. See for example the Untitled Letter the FDA sent to the now defunct BioD, in which they objected to BioD’s stable of injectable, amniotic membrane-containing products precisely because the products were injectable. Just to be clear, the FDA might also object to amniotic fluid-derived products that contain viable cells, but in the case of BioD’s family of products the issue was injectable membrane bits.
And then there is Slide 22. Davidson marshals “facts” to support why physicians should be using his preferred amniotic tissue-derived product. One of his facts is the previously mentioned unsubstantiated claim about the product having 44% stem cells. He also claims that some of the stem cells are “pluripotent”. I sure hope not, since the cells I know as pluripotent have a tendency to form teratomas, which is a bad thing.
To establish the superiority of the amniotic product, he points out that there just aren’t that many stem cells in bone marrow, by citing an unnamed reference that indicated that bone marrow (BMA) has 1,500 CFU-F (a biomarker for MSCs) per mL, while another unnamed reference stated a level of “2,300 CFU-f/ml (donors<1 yo)”. I am not sure what Davidson is trying to get at with “donors<1 yo”, but I have seen pediatric (11-16 yo) bone marrow CFU-F levels of 4,000 CFU-F per mL. In any event, the numbers game Davidson engages in misses the point, which is, do you have enough MSCs to achieve a therapeutic benefit?
Davidson’s last bullet point on Slide 22 is that “BMC cells are senile”. I am not sure what he means by calling cells “senile”, but perhaps he is trying to imply that BMC cells from old people aren’t effective. What rubbish. I wrote recently about a clinical study that Dr. Philippe Hernigou reported on during a presentation at the 2017 general meeting of ASIPP, in which he showed that 80+ year old patients suffering from bone-on-bone knee osteoarthritis when treated with their concentrated bone marrow showed an equivalent return to quality of life metrics for the BMC-treated knee as for the total knee replacement they had already undergone in the other knee. Now, if the old folks’ MSCs are senile, how could they be as effective in reducing pain and improving quality of life as a total knee replacement? More wishful thinking on Davidson’s part.
Just so you don’t get the impression I am picking unfairly on Dr. Davidson, I will give him credit where credit is due: he correctly stated that older people had around 500 CFU-F per mL of BMA; unfortunately, it was in 80 year old patients, and not 60 year old patients as Davidson implied on Slide 22—at least according to Dr. Hernigou during his ASIPP talk. If you aren’t familiar with the work of Dr. Philippe Hernigou, he is the physician who has been using BMC to treat orthopedic pathologies in patients ranging from their teens to over 90 years of age for over 30 years.
The last point I will make concerns a statement from Davidson on Slide 36 in which I think he indicates that you should combine the amniotic fluid-derived product with 1% Lidocaine. From what I understand, combining viable cells with agents like Lidocaine usually results in dead cells. On the other hand, maybe it doesn’t matter with amniotic fluid-derived preparations, since it has been reported that these products mostly have dead cells anyway.
While I have focused on what seem to me to be errors in Davidson’s Powerpoint presentation, don’t think for a minute that I believe the product he embraces is FDA-compliant. On the contrary, if there are viable, donor-derived cells in the product, it definitely isn’t compliant. And with extremely small particles of amniotic tissue present, I doubt that the FDA would consider it to meet the standard of homologous use. But it shouldn’t surprise anyone that Dr. Davidson doesn’t bring up FDA compliance in any of his PPt slides. Why spoil the party?